Hims & Hers Under Investigation for Securities Violations Amid FDA Scrutiny
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
0mins
Should l Buy HIMS?
Source: Businesswire
- Legal Investigation Launched: The Schall Law Firm is investigating Hims & Hers Health, Inc. for potential securities law violations, particularly focusing on whether the company made false or misleading statements that could have led to investor losses.
- FDA Statement Impact: The FDA has announced its intent to restrict GLP-1 active pharmaceutical ingredients intended for non-FDA-approved compounded drugs, directly affecting Hims & Hers' market practices and potentially leading to stricter regulatory scrutiny.
- Increased Litigation Risk: Novo Nordisk has filed a lawsuit against Hims & Hers seeking to bar the sale of compounded weight loss drugs, which not only heightens the company's legal risks but may also impact its future product lines and market strategies.
- Significant Stock Decline: On February 9, 2026, shares of Hims & Hers fell by over 17.8% during trading, reflecting investor concerns regarding the legal and regulatory challenges the company faces, which could further erode market confidence.
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Analyst Views on HIMS
Wall Street analysts forecast HIMS stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for HIMS is 42.88 USD with a low forecast of 29.00 USD and a high forecast of 85.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
12 Analyst Rating
2 Buy
7 Hold
3 Sell
Hold
Current: 23.020
Low
29.00
Averages
42.88
High
85.00
Current: 23.020
Low
29.00
Averages
42.88
High
85.00
About HIMS
Hims & Hers Health, Inc. provides a consumer-first platform, which helps customers to fulfill their health and wellness needs. Its platform includes access to a provider network, a clinically focused electronic medical record system, digital prescriptions, cloud pharmacy fulfillment, and personalization capabilities. Its digital platform enables access to treatments for a range of chronic conditions, including those related to sexual health, hair loss, dermatology, mental health, and weight loss. It connects patients to licensed healthcare professionals who can prescribe medications when appropriate and prescriptions are fulfilled online through licensed pharmacies on a subscription basis. It also offers access to a range of health and wellness products designed to meet individual needs, which can include curated prescription and non-prescription products. Through its mobile applications, consumers can access a range of educational programs, wellness content, and other services.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Hims & Hers Stock Plummets 16% After FDA Restrictions on GLP-1 Drugs
- Stock Price Drop: Hims & Hers experienced a nearly 16% drop in stock price on February 9 after deciding to halt plans for a copycat GLP-1 pill, which significantly impacted investor confidence and led to a substantial decrease in market capitalization.
- Tightening FDA Regulations: The FDA's announcement to restrict GLP-1 active pharmaceutical ingredients for non-FDA-approved compounded drugs directly targets companies like Hims & Hers, indicating a more challenging market environment ahead.
- Legal Litigation Risks: Following Hims & Hers' announcement of a $49 copycat Wegovy pill, Novo Nordisk filed a patent infringement lawsuit, causing the stock to plummet, highlighting the market's heightened concern over legal risks.
- Uncertain Market Outlook: Although Hims & Hers reported a 74% year-over-year revenue growth in the first nine months of 2025, the sustainability of revenue from GLP-1 drugs is questioned due to regulatory risks and increasing competition, leading investors to adopt a cautious stance on the company's future.
See More
FDA Moves to Restrict GLP-1 Ingredients in Compounded Drugs
- FDA Regulatory Action: The U.S. FDA announced it would take 'decisive steps' to restrict unapproved GLP-1 ingredients, a move that could significantly impact companies like Hims & Hers, leading to stricter compliance requirements and potential market disruptions.
- Hims & Hers Stock Volatility: After announcing a copycat GLP-1 drug, Hims & Hers' stock surged but quickly fell due to a patent lawsuit from Novo Nordisk, resulting in a more than 58% decline over the past year, indicating market concerns about its future profitability.
- Revenue Growth Amid Legal Risks: Despite Hims & Hers achieving a 74% year-over-year revenue growth in the first nine months of 2025, driven by demand for alternative weight-loss treatments, the FDA's regulatory actions and Novo Nordisk's lawsuit could undermine its market position and affect future revenue sustainability.
- Intensifying Market Competition: With rising demand for GLP-1 drugs and increasing competition, Hims & Hers may face greater pricing pressures, and although it thrived in the telehealth market during the pandemic, the current legal and regulatory landscape prompts investors to adopt a cautious outlook on its prospects.
See More
Capital Group Identifies Attractive Dividend Stock Opportunities
- Dividend Stock Appeal: Christopher Buchbinder from Capital Group highlights the attractiveness of dividend stocks, particularly those rated investment grade with a long history of income payments, which has allowed the CGDV fund to outperform the S&P 500 in down markets.
- Tech Sector Allocation: As of January 31, 26.8% of CGDV's assets are allocated to information technology, particularly semiconductor companies, reflecting the team's confidence in a sustainable AI investment cycle, with expectations that AI will dramatically change lives over the next 5-10 years.
- Energy Sector Opportunities: Although energy comprises only 6.4% of CGDV's portfolio, Buchbinder sees an upcycle in the oil field services sector over the next few years, particularly with Halliburton's collaboration with VoltaGrid to manufacture power systems for AI data centers, indicating long-term growth potential.
- Healthcare Investment: CGDV's largest healthcare holding is Eli Lilly at 3.86%, with Buchbinder believing that the long-term trend of GLP-1 drugs will transform the healthcare landscape in the U.S., positioning Eli Lilly as the market leader while awaiting FDA approval for its oral GLP-1 drug.
See More
Hims & Hers Under Investigation for Securities Violations Amid FDA Scrutiny
- Legal Investigation Launched: The Schall Law Firm is investigating Hims & Hers Health, Inc. for potential securities law violations, particularly focusing on whether the company made false or misleading statements that could have led to investor losses.
- FDA Statement Impact: The FDA has announced its intent to restrict GLP-1 active pharmaceutical ingredients intended for non-FDA-approved compounded drugs, directly affecting Hims & Hers' market practices and potentially leading to stricter regulatory scrutiny.
- Increased Litigation Risk: Novo Nordisk has filed a lawsuit against Hims & Hers seeking to bar the sale of compounded weight loss drugs, which not only heightens the company's legal risks but may also impact its future product lines and market strategies.
- Significant Stock Decline: On February 9, 2026, shares of Hims & Hers fell by over 17.8% during trading, reflecting investor concerns regarding the legal and regulatory challenges the company faces, which could further erode market confidence.
See More
Competitive Analysis of Novo Nordisk and Eli Lilly
- Eli Lilly's Growth Momentum: Eli Lilly has achieved remarkable results with its GLP-1 products, Mounjaro and Zepbound, generating nearly $12 billion in quarterly sales and projecting full-year revenue between $80 billion and $83 billion, indicating a growth rate as high as 27%, showcasing strong market demand and profitability.
- Novo Nordisk's Challenges: Novo Nordisk is facing intense competition, projecting a decline in adjusted sales growth of 5% to 13% this year, reflecting its unfavorable market position, and is currently engaged in a patent lawsuit against Hims & Hers to protect its market share.
- Significant Valuation Discrepancy: Eli Lilly trades at a price-to-earnings ratio of about 46, while Novo Nordisk stands at just 13, indicating a stark difference in investor sentiment, which may suggest over-optimism for Eli Lilly and potential undervaluation for Novo Nordisk.
- Investment Outlook Analysis: Despite current challenges, Novo Nordisk's rollout of its GLP-1 weight loss pill offers hope for future growth, and considering its more attractive valuation, it may represent a better long-term investment choice compared to Eli Lilly.
See More
Bank of America Lowers Hims & Hers Price Target
- Price Target Reduction: Bank of America has lowered its price target for Hims & Hers, primarily due to FDA uncertainty and slowing GLP-1 sales, indicating market concerns regarding the company's future performance.
- Revenue Risk Warning: Analysts have highlighted that increasing uncertainty around FDA approvals may pose downside risks to Hims & Hers' revenue and profits, potentially impacting investor confidence.
- Uncertain Profit Outlook: Ahead of the upcoming earnings report, Bank of America expresses concerns over Hims & Hers' profit outlook, suggesting that the current market environment may lead to performance falling short of expectations.
- Market Reaction Anticipation: Given the price target reduction and warnings about profit risks, the market may react negatively to Hims & Hers' stock performance, prompting investors to carefully assess its future prospects.
See More
Hims & Hers Stock Plummets 16% After FDA Restrictions on GLP-1 Drugs
- Stock Price Drop: Hims & Hers experienced a nearly 16% drop in stock price on February 9 after deciding to halt plans for a copycat GLP-1 pill, which significantly impacted investor confidence and led to a substantial decrease in market capitalization.
- Tightening FDA Regulations: The FDA's announcement to restrict GLP-1 active pharmaceutical ingredients for non-FDA-approved compounded drugs directly targets companies like Hims & Hers, indicating a more challenging market environment ahead.
- Legal Litigation Risks: Following Hims & Hers' announcement of a $49 copycat Wegovy pill, Novo Nordisk filed a patent infringement lawsuit, causing the stock to plummet, highlighting the market's heightened concern over legal risks.
- Uncertain Market Outlook: Although Hims & Hers reported a 74% year-over-year revenue growth in the first nine months of 2025, the sustainability of revenue from GLP-1 drugs is questioned due to regulatory risks and increasing competition, leading investors to adopt a cautious stance on the company's future.
See More
FDA Moves to Restrict GLP-1 Ingredients in Compounded Drugs
- FDA Regulatory Action: The U.S. FDA announced it would take 'decisive steps' to restrict unapproved GLP-1 ingredients, a move that could significantly impact companies like Hims & Hers, leading to stricter compliance requirements and potential market disruptions.
- Hims & Hers Stock Volatility: After announcing a copycat GLP-1 drug, Hims & Hers' stock surged but quickly fell due to a patent lawsuit from Novo Nordisk, resulting in a more than 58% decline over the past year, indicating market concerns about its future profitability.
- Revenue Growth Amid Legal Risks: Despite Hims & Hers achieving a 74% year-over-year revenue growth in the first nine months of 2025, driven by demand for alternative weight-loss treatments, the FDA's regulatory actions and Novo Nordisk's lawsuit could undermine its market position and affect future revenue sustainability.
- Intensifying Market Competition: With rising demand for GLP-1 drugs and increasing competition, Hims & Hers may face greater pricing pressures, and although it thrived in the telehealth market during the pandemic, the current legal and regulatory landscape prompts investors to adopt a cautious outlook on its prospects.
See More
Capital Group Identifies Attractive Dividend Stock Opportunities
- Dividend Stock Appeal: Christopher Buchbinder from Capital Group highlights the attractiveness of dividend stocks, particularly those rated investment grade with a long history of income payments, which has allowed the CGDV fund to outperform the S&P 500 in down markets.
- Tech Sector Allocation: As of January 31, 26.8% of CGDV's assets are allocated to information technology, particularly semiconductor companies, reflecting the team's confidence in a sustainable AI investment cycle, with expectations that AI will dramatically change lives over the next 5-10 years.
- Energy Sector Opportunities: Although energy comprises only 6.4% of CGDV's portfolio, Buchbinder sees an upcycle in the oil field services sector over the next few years, particularly with Halliburton's collaboration with VoltaGrid to manufacture power systems for AI data centers, indicating long-term growth potential.
- Healthcare Investment: CGDV's largest healthcare holding is Eli Lilly at 3.86%, with Buchbinder believing that the long-term trend of GLP-1 drugs will transform the healthcare landscape in the U.S., positioning Eli Lilly as the market leader while awaiting FDA approval for its oral GLP-1 drug.
See More
Hims & Hers Under Investigation for Securities Violations Amid FDA Scrutiny
- Legal Investigation Launched: The Schall Law Firm is investigating Hims & Hers Health, Inc. for potential securities law violations, particularly focusing on whether the company made false or misleading statements that could have led to investor losses.
- FDA Statement Impact: The FDA has announced its intent to restrict GLP-1 active pharmaceutical ingredients intended for non-FDA-approved compounded drugs, directly affecting Hims & Hers' market practices and potentially leading to stricter regulatory scrutiny.
- Increased Litigation Risk: Novo Nordisk has filed a lawsuit against Hims & Hers seeking to bar the sale of compounded weight loss drugs, which not only heightens the company's legal risks but may also impact its future product lines and market strategies.
- Significant Stock Decline: On February 9, 2026, shares of Hims & Hers fell by over 17.8% during trading, reflecting investor concerns regarding the legal and regulatory challenges the company faces, which could further erode market confidence.
See More
Competitive Analysis of Novo Nordisk and Eli Lilly
- Eli Lilly's Growth Momentum: Eli Lilly has achieved remarkable results with its GLP-1 products, Mounjaro and Zepbound, generating nearly $12 billion in quarterly sales and projecting full-year revenue between $80 billion and $83 billion, indicating a growth rate as high as 27%, showcasing strong market demand and profitability.
- Novo Nordisk's Challenges: Novo Nordisk is facing intense competition, projecting a decline in adjusted sales growth of 5% to 13% this year, reflecting its unfavorable market position, and is currently engaged in a patent lawsuit against Hims & Hers to protect its market share.
- Significant Valuation Discrepancy: Eli Lilly trades at a price-to-earnings ratio of about 46, while Novo Nordisk stands at just 13, indicating a stark difference in investor sentiment, which may suggest over-optimism for Eli Lilly and potential undervaluation for Novo Nordisk.
- Investment Outlook Analysis: Despite current challenges, Novo Nordisk's rollout of its GLP-1 weight loss pill offers hope for future growth, and considering its more attractive valuation, it may represent a better long-term investment choice compared to Eli Lilly.
See More
Bank of America Lowers Hims & Hers Price Target
- Price Target Reduction: Bank of America has lowered its price target for Hims & Hers, primarily due to FDA uncertainty and slowing GLP-1 sales, indicating market concerns regarding the company's future performance.
- Revenue Risk Warning: Analysts have highlighted that increasing uncertainty around FDA approvals may pose downside risks to Hims & Hers' revenue and profits, potentially impacting investor confidence.
- Uncertain Profit Outlook: Ahead of the upcoming earnings report, Bank of America expresses concerns over Hims & Hers' profit outlook, suggesting that the current market environment may lead to performance falling short of expectations.
- Market Reaction Anticipation: Given the price target reduction and warnings about profit risks, the market may react negatively to Hims & Hers' stock performance, prompting investors to carefully assess its future prospects.
See More
